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Trial registered on ANZCTR
Registration number
ACTRN12611001227987
Ethics application status
Approved
Date submitted
27/11/2011
Date registered
30/11/2011
Date last updated
30/11/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
The importance of nerve fibers and macrophage cell count in the diagnosis of endometriosis
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Scientific title
The importance of nerve fibers and macrophage cell count in the diagnosis of endometriosis
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Secondary ID [1]
273478
0
'Nil'
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
279266
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Condition category
Condition code
Reproductive Health and Childbirth
279464
279464
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Endometrial nerve fibers and macrophage cell count using endometrial biopsy. Just before the patient's planned operation starts, endometrial biopsies are taken. This is done with the help of an endometrial sampling cannula. This procedure is done only once and after the induction of anesthesia and takes approximately 5 minutes. Also some patients who are previously operated and have endometrial samples kept in the pathology lab are involved in the study.
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Intervention code [1]
283793
0
Diagnosis / Prognosis
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Comparator / control treatment
Control group consists of biopsies and endometrial samples of patients who are not diagnosed to have endometriosis during operation.
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Control group
Active
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Outcomes
Primary outcome [1]
286023
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Increase in the number of endometrial nerve fibers
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Assessment method [1]
286023
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Timepoint [1]
286023
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After all biopsies are taken, all of the samples are evaluated together
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Secondary outcome [1]
295013
0
Increase in the number of endometrial macrophage cells
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Assessment method [1]
295013
0
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Timepoint [1]
295013
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After all biopsies are taken, all of the samples are evaluated together
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Eligibility
Key inclusion criteria
Cystoma ovarii, chronic pelvic pain, infertility, myoma uteri, tubal ligation,
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Minimum age
24
Years
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Maximum age
47
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Malignancy, adenomyosis
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/10/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3979
0
Turkey
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State/province [1]
3979
0
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Funding & Sponsors
Funding source category [1]
284268
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Self funded/Unfunded
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Name [1]
284268
0
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Address [1]
284268
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Country [1]
284268
0
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Primary sponsor type
Individual
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Name
Cihan Cetin
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Address
AYDINCIK DEVLET HASTANESI KADIN HAST. VE DOGUM POLIKLINIGI AYDINCIK/MERSIN/TURKEY
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Country
Turkey
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Secondary sponsor category [1]
283220
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None
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Name [1]
283220
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Address [1]
283220
0
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Country [1]
283220
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
286228
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ISTANBUL UNIVERSITESI ISTANBUL TIP FAKULTESI KLINIK ARASTIRMALAR ETIK KURULU
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Ethics committee address [1]
286228
0
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Ethics committee country [1]
286228
0
Turkey
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Date submitted for ethics approval [1]
286228
0
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Approval date [1]
286228
0
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Ethics approval number [1]
286228
0
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Summary
Brief summary
The aim of the study is to determine whether the detection of nerve fibers and increased number of macrophage cells in the layer of endometrium can be used in the diagnosis of endometriosis
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
33446
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Address
33446
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Country
33446
0
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Phone
33446
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Fax
33446
0
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Email
33446
0
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Contact person for public queries
Name
16693
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Cihan Cetin
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Address
16693
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Aydincik Devlet Hastanesi Kadin Hastaliklari ve Dogum Klinigi
Aydincik/Mersin/Turkey
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Country
16693
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Turkey
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Phone
16693
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+905332241033
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Fax
16693
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Email
16693
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[email protected]
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Contact person for scientific queries
Name
7621
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Cihan Cetin
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Address
7621
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Aydincik Devlet Hastanesi Kadin Hastaliklari ve Dogum Klinigi
Aydincik/Mersin/Turkey
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Country
7621
0
Turkey
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Phone
7621
0
+905332241033
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Fax
7621
0
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Email
7621
0
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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